Power wheelchair (Model: JMPW-01W)

K232783 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · ITI · Jan 19, 2024 · Physical Medicine

Device Facts

• Record ID: K232783
• Device Name: Power wheelchair (Model: JMPW-01W)
• Applicant: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Jan 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Power Wheelchair (Model: JMPW-01W) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Story

Motor-driven power wheelchair; provides mobility for disabled/elderly persons limited to seated position. Input: user manipulation of joystick controller; determines speed/direction. Operation: joystick signals processed by electronic controller; drives two rear wheels via brushless DC motors; automatic electromagnetic brake system engages upon joystick release. Output: physical movement of wheelchair. Used in indoor/outdoor environments; operated by patient. Benefits: assists mobility for action-handicapped/disabled individuals. Healthcare provider role: none; device is OTC.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing per ISO 7176 series (stability, braking, energy consumption, dimensions, strength, climatic, obstacle climbing, EMC, and battery/charger safety).

Technological Characteristics

Alloy steel frame; brushless DC motors (24V, 250W); lead-acid battery (24V 20Ah); joystick controller. Dimensions: 870mm L x 710mm W. Electromagnetic braking. Compliance with ISO 7176 series (1-16, 21, 25). Biocompatibility per ISO 10993-5/10.

Indications for Use

Indicated for disabled or elderly persons with mobility difficulties limited to a seated position requiring indoor and outdoor transportation.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Power Wheelchair Model A08 (K163204)

Submission Summary (Full Text)

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January 19, 2024

Jiangsu Jumao x-Care Medical Equipment Co., Ltd % Jarvis Wu Senior Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K232783

Trade/Device Name: Power wheelchair (Model: JMPW-01W) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 26, 2023 Received: December 26, 2023

Dear Jarvis Wu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices

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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K232783

Device Name Power wheelchair (Model: JMPW-01W)

Indications for Use (Describe)

The Power Wheelchair (Model: JMPW-01W) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------|
| □ Prescription Use (Part 21 CFR 801 Subpart D) | \[X] Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

# K232783

#### Document Prepared Date: 2024/01/09

#### A. Applicant:

Jiangsu Jumao x-care Medical Equipment Co., Ltd Address: No.36 Danyan Road, Danyang, Jiangsu, China Contact Person: Weixia Shi Tel: [phone]

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: [phone] Email: zxfda(@sungoglobal.com

#### B. Device:

Trade Name: Power wheelchair Common Name: Powered wheelchair Model: JMPW-01W

Regulatory Information Classification Name: Powered wheelchair Classification: Class II Product code: ITI

Regulation Number: 890.3860

Review Panel: Physical Medicine

#### C. Predicate device:

510k number: K163204 Device Name: Power Wheelchair Model: A08 Kunshan Aoshida Electric Technology Co., Ltd.

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#### D. Indications for use of the device:

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

#### E. Device Description:

This Power wheelchair is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger.

The device is powered by Lead-acid Battery pack (24V 20Ah) with 8 miles range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

#### F. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro ハ Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And > Skin Sensitization
- ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability ム
- ISO 7176-2:2017. Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs >
- ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes >
- A ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and wheelchairs for determination of theoretical distance range
- ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall A dimensions, mass and maneuvering space
- ISO 7176-6: 2018, Wheelchairs Part 6: Determination of maximum speed, acceleration A and deceleration of Powered Wheelchairs
- > ISO 7176-7, Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and > fatigue strengths
- ISO 7176-9:2009, Wheelchairs Part 9: Climatic tests for Powered Wheelchairs >
- ISO 7176-10:2008, Wheelchairs Part 10: Determination of obstacle-climbing ability of >

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electrically powered wheelchairs

- ISO 7176-11:2012 Wheelchairs Part 11: Test dummies. >
- > ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- ) ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and wheelchairs - Requirements and test methods
- > ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 7176-16:2012 Wheelchairs Part 16: Resistance to ignition of postural support devices. >
- ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic > compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
- > ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs

## G. Clinical Test Conclusion

No clinical study is included in this submission.

| Elements of<br>Comparison | Subject Device | Predicate Device (K163204) | Remark |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Jiangsu Jumao x-care<br>Medical Equipment Co.,Ltd | Kunshan Aoshida Electric<br>Technology Co., Ltd. | - |
| Common or Usual<br>name | Power Wheelchair | Power Wheelchair | S.E. |
| Model(s) | JMPW-01W | A08 | -- |
| Indications for use | It is a motor driven, indoor<br>and outdoor transportation<br>vehicle with the intended use<br>to provide mobility to a<br>disabled or elderly person<br>limited to a seated position. | It is a motor driven, indoor<br>and outdoor transportation<br>vehicle with the intended use<br>to provide mobility to a<br>disabled or elderly person<br>limited to a seated position. | S.E. |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E |
| Number of wheels | 4, including two front<br>wheels and two rear Wheels | 4, including two front wheels<br>and two rear Wheels | S.E |
| Function of wheels | Front wheels: driven<br>wheels suitable for rotation,<br>acceleration, retrograde Rear<br>wheels: driving wheels to<br>control the speed and<br>direction | Front wheels: driven wheels<br>suitable for rotation,<br>acceleration, retrograde Rear<br>wheels: driving wheels to<br>control the speed and<br>direction | S.E |
| Movement control<br>method | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the rear<br>wheels | Direct drive on the rear<br>wheels | S.E |
| Brake system | Automatic electromagnetic<br>brake system | Intelligent regenerative<br>electromagnetic brake | S.E |
| Free-wheel mode | Yes | Yes | S.E |
| Braking distance | 1m | 1m | S.E |
| Maximum safe<br>operational<br>incline degree | 6° | 0-12° | S.E. |
| Battery charger | Off-board charger<br>Input: 110-240V, 50/60Hz<br>Output: 24 Vdc, 2A; | Off-board charger<br>Input: 110-240V, 50/60Hz,<br>Output: 24 Vdc, 2A; | S.E |
| Main frame<br>material | Alloy Steel | Aluminum | Analysis:<br>Difference of the<br>materials will not<br>raise safe and<br>effectiveness<br>concerns. |
| Back cushion | Polyvinyl chloride | PU foam covered by nylon<br>fabric cloth | The<br>biocompatibility<br>tests have been<br>conducted to verify<br>the safety and<br>effectiveness of the<br>material. |
| Seat cushion | Polyvinyl chloride | PU foam covered by nylon<br>fabric cloth | |
| Overall length | 870mm | 890 mm (35") | Analysis:<br>Minor differences in<br>the dimensions will |
| Overall width | 710mm | 603 mm (23.7") | not impact the<br>safety and<br>effectiveness of the<br>substantial<br>equivalence. |
| Stowage length | 670mm | 324 mm (12.8") | |
| Stowage width | 560mm | 603 mm (23.7") | |
| Stowage height | 615mm | 670 mm (26.4") | |
| Front wheel<br>size/type | 7.5"x2" Flat Free Tires | 7" x 2" Flat Free Tires | S.E |
| Rear wheel<br>size/type | 9"x2.7" Flat Free Tires | 10" x 2.35" Flat Free Tires | S.E |
| Max speed Forward | Up to 6 km/h (3.7 mp/ h),<br>adjustable | 7 km/h (4.4mph) | Analysis:<br>Slightly difference<br>on the parameter<br>will not affect the<br>safety and<br>performance of the<br>subject device as all<br>related stability tests<br>are performed<br>according to<br>standard ISO 7176 |
| | | | 6:2018. |
| Max loading<br>weight | 250 lbs (113.4kg) | 220 lbs (100 kg) | S.E |
| Battery | Lead-acid 24V 20Ah | Li-ion 24V 20Ah | Analysis:<br>The subject device<br>complies with ISO<br>7176-25:<br>2013<br>Wheelchairs - Part<br>25: Batteries<br>and<br>chargers<br>for<br>powered<br>wheelchairs<br>and<br>EMC testing, these<br>differences do not<br>affect safety<br>and<br>effectiveness. |
| Maximum<br>distance of travel<br>on the fully<br>charged battery | 8 miles | 20 km (12.43miles) | Analysis:<br>The subject device<br>complies with ISO<br>7176-4:<br>2008<br>Wheelchairs - Part<br>4:<br>Energy<br>consumption<br>of<br>electric wheelchairs<br>and scooters for<br>determination<br>of<br>theoretical distance<br>range,<br>these<br>differences do not<br>affect safety<br>and<br>effectiveness. |
| Motor | Brushless DC motor;<br>24VDC; 250W; 2pcs | Brushless DC motor;<br>24VDC; 250W; 2pcs | S.E |
| Electronic<br>controller | Yanteon Electromechanical<br>Technology (Shanghai) Co.,<br>Ltd, Y2450C-JW01, 50A | Yisheng Electric Co. Ltd ,<br>WS-1, 40A | Analysis :<br>Difference on<br>output current will<br>affect charging time<br>of the subject<br>device, which will<br>not cause safety and<br>effectiveness<br>concerns. |
| Turning Radius | 900mm | 800mm | S.E |
| Maximum<br>obstacle climbing | 40 mm | 40 mm | S.E |
| Ground clearance | 63.5 mm(2.5") | 63.5 mm(2.5") | S.E |
| Item | Proposed Device | Predicate Devices | Results |
| Biocompatibility | All user directly contacting<br>materials are compliance with<br>ISO10993-5 and<br>ISO10993-10 requirements.<br>(Having long-term skin contact<br>of greater than 30 days) | All user directly contacting<br>materials are compliance with<br>ISO10993-5 and<br>ISO10993-10 requirements. | S.E. |
| EMC | ISO7176-21 | ISO7176-21 | S.E. |
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |

#### H. Comparison with predicate Device

Table 1 General Comparison

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## I. Difference analysis

The design and technological characteristics of the Power Wheelchair is similar to the predicates chosen. There are minor differences between the devices including Overall & Stowage dimension Max speed Forward, Battery type, Maximum distance of travel on the fully charged battery and Controller output current. All of the parameter with difference have been tested according to ISO7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Wheelchair is substantially equivalent (SE) to The Power Wheelchair (K163204).

## Table 2 Safety comparison

### Table 3 Safety comparison

| Item | Proposed Device | Predicate Devices | Results |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ISO7176-1 | The Static stability has been<br>determined after the testing according<br>to the ISO 7176-1, and test results<br>meet its design specification. | The Static stability has been<br>determined after the testing according<br>to the ISO 7176-1, and test results meet<br>its design specification. | S.E. |
| ISO7176-2 | The dynamic stability has been<br>determined after the testing according<br>to the ISO 7176-2, and test results<br>meet its design specification. | The dynamic stability has been<br>determined after the testing according<br>to the ISO 7176-2, and test results meet<br>its design specification. | S.E. |
| ISO7176-3 | The effectiveness of brakes has been<br>determined after the testing according<br>to the ISO 7176-3, and test results<br>meet its design specification. | The effectiveness of brakes has been<br>determined after the testing according<br>to the ISO 7176-3, and test results meet<br>its design specification. | S.E. |
| ISO7176-4 | The theoretical distance range has<br>been determined after the testing<br>according to the ISO 7176-4, and test<br>results meet its design specification. | The theoretical distance range has<br>been determined after the testing<br>according to the ISO 7176-4, and test<br>results meet its design specification. | S.E. |
| ISO7176-5 | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5, | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5, | S.E. |
| ISO7176-6 | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5, | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5, | S.E. |
| | | | |
| ISO7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7, | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7, | S.E. |
| ISO7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | S.E. |
| ISO7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | S.E. |
| ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | S.E. |
| ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | S.E. |
| ISO7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | S.E. |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | S.E. |
| ISO7176-16 | The performance of resistance to ignition meet the requirements of ISO 7176-16 | The performance of resistance to ignition meet the requirements of ISO 7176-16 | S.E. |
| ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | S.E. |
| ISO7176-25 | The performance of batteries and charger of device meet the Requirements in Clause 5 and 6 of ISO 7176-25 | The performance of batteries and charger of device meet the Requirements in Clause 5 and 6 of ISO 7176-25 | S.E. |

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#### J. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, power wheelchair, JMPW-01W, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K163204.